Clinical Research Regulatory Coordinator, School Of Medicine, Clinical Research Office

Virginia Commonwealth University (VCU) School of Medicine is a premier academic medical center located in the heart of Richmond. Accounting for almost half of VCU's sponsored research, the School of Medicine is internationally recognized for patient care and education. All full-time university staff are eligible for VCU's generous benefits package that includes: competitive health benefits, paid annual and holiday leave, retirement planning and savings options, tax-deferred annuity and cash match programs, Virginia Retirement System (VRS), professional development & certifications, tuition waiver, parental leave, caregiving leave and community service leave. Learn more about VCU's benefits here: https://hr.vcu.edu/careers-at-vcu/why-work-at-vcu/

Virginia Commonwealth University is an equal opportunity, affirmative action university providing access to education and employment without regard to race, color, religion, national origin, age, sex, political affiliation, veteran status, genetic information, sexual orientation, gender identity, gender expression, or disability.

Position Summary and Primary Responsibilities:

The School of Medicine (SOM) Clinical Research Office (CRO) is seeking a candidate with strong skills in clinical research coordination and regulatory management to join our team as a Clinical Research Regulatory Coordinator. This position is a key part of the team focused on supporting SOM clinical research study teams with the management of clinical trials in a positive and dynamic environment. The SOM is committed to supporting clinical researchers in advancing medical science in our region. Working under the direction of the Associate Director for Clinical Research Operations, key responsibilities for this position include:

Core Responsibilities:

Responsibility 1 (60%): Regulatory Management and Study Activation

• Provide direct regulatory management for assigned SOM Clinical Trials

• Maintain and organize regulatory documents for SOMCRO studies

• Prepare and manage IRB documents and protocols for submission

• Ensure regulatory compliance

• Possess knowledge of and experience working within FDA guidelines

• Act as liaison between Regulatory Bodies, VCU, and the SOM personnel

• Possess knowledge of GCP/ICH guidelines

• Ensure adherence to all human subject protection and IRB regulations required for clinical research

• Understand duty to report obligations related to research conduct

• Familiar with IRB (and Advarra, WIRB, as applicable) to be able to assist with submissions

• Keeps PI and leadership informed regarding study regulatory operations and activation progress

• Ensures that study startup is carried out according to sponsor/funding agency requirements

• Obtains all required internal approvals (ie: SOMCT, OSP, etc.)

• Follow all VCU and School of Medicine procedures for activation and management of clinical research

• Responsible for ensuring clinical trials are initiated in Veeva SiteVault for e-Regulatory requirements

Responsibility 2 (20%): Support and Assist SOM Study Teams

• Provide education and guidance to investigators as it relates to regulatory compliance

• Work with SOMCRO Training Coordinator to develop tools that align with regulatory requirements

• Coordinate site selection visits and study selection activities for assigned studies.

• Ensure OnCore study team task lists are current throughout the activation process.

• Participate in SOM pre-study planning meetings and follow-up action items.

• Complete PROC and intake forms for studies assigned from initiation

• Keep PI and study team informed regarding study regulatory operations and activation progress.

• Coordinate with PIs to support the development of coverage analysis, budget and time/effort estimates

• Stay up to date on internal clinical trial submission policies and educate study teams on changes.

• Assist with training CRCs on required regulatory and IRB ongoing study documentation

Responsibility 3 (10%): Establish Standard Operating Procedures to support Regulatory Compliance

• Create Standard Operations Procedures that align VCU Clinical Research Regulatory best practices

• Ensure compliance with School of Medicine policies and procedures

• Follow VCU and SOM internal processes to ensure compliance with VCU policies related to research activities and ensure compliance with federal and state regulatory standards.

• Lead the development of best practice guidance and work aids for CRCs in areas such as: study activation, study coordination, data management, and records management.

Responsibility 4 (10%): Excellence in Customer Service and Collaboration

• Provide ongoing support for clinical research operations and administration in SOM including ongoing communication with departments/divisions, investigators, administrators, and staff.

• Work in collaboration with the SOMCTC Senior Program Manager to develop tools for centralized staff

• Serve as an ongoing resource for providing information and expert advice on regulatory compliance.

• Regularly assess VCU SOM CRC performance by performing quality control check

Minimum Hiring Standards:

• Demonstrated knowledge of federal regulations as well as protection of human subjects and HIPAA

• Must have ability to analyze, interpret, and implement complex Federal, State, and sponsor regulations

• Must be knowledgeable of GCP/ICH guidelines for clinical studies.

• Bachelor's degree or equivalent experience

• At least 2 years of direct Clinical Research Coordinator experience.

• 1 or more years' experience in Clinical Research Regulatory affairs.

• Demonstrated understanding of clinical research including all types and funding sources

• Maintain CITI credentials for Human Subjects Protection and Good Clinical Practice (GCP)

• Excellent oral and written communication skills

• Must possess the ability to set priorities, make timely decisions and meet deadlines.

• Ability to work collaboratively in a large and complex organization.

• Comfortability working in and fostering a diverse faculty, staff, and student environment

• Extremely organized and detail-oriented

• Strong communications skills, attention to detail and time management skills

• Must have a demonstrated commitment to fostering diversity and inclusion in past experiences or a commitment to do so as a staff member at VCU.

Preferred Hiring Standards:

• Regulatory management of multi-site studies strongly preferred

• Clinical research certification or ability to obtain.

• Experience in an academic medical center environment.

• Prior experience using OnCore or other clinical trial management systems preferred.

• Advanced degree in healthcare, research, or education.

• Knowledge of VCU and/or VCU Health

• Experience utilizing EPIC (Electronic Medical Record)

• Proficient with Microsoft Office Suite

• Active clinical research certification, e.g., SOCRA, ACRP, or ability to obtain certification.

Position is remote-hybrid eligible (40%-60% remote work). Selected candidate must be able to come into the office on VCU's MCV-Health Campus when needed as office days may vary weekly.

Position will remain open until filled.

The School of Medicine continuously strives for our workplace and learning environment to reflect the demographic and social milieu of the communities we serve. All qualified applicants are encouraged to apply.

VCU is committed to hiring veterans! VCU will include a veteran's period(s) of military service in the calculation of their annual leave accrual rate. This may provide veterans with an increased leave accrual!